Viz.ai has received a de novo approval from the U.S. Food and Drug Administration (FDA) for its new artificial intelligence (AI) algorithm designed to identify signs of hypertrophic cardiomyopathy (HCM) in routine electrocardiograms (ECGs).
Viz HCM, the first AI model specifically crafted with detecting HCM in mind, automatically reviews ECGs as they are performed, alerting cardiologists and other members of the heart team so they can personally review the imaging results and proceed as necessary.
“Hypertrophic cardiomyopathy is a devastating disease that is often undetected until it is too late,” Chris Mansi, MD, CEO and co-founder at Viz.ai, said in a prepared statement. “The addition of Viz HCM to the Viz.ai Platform aims to improve outcomes for patients with HCM by getting them to the right specialist faster. We are thrilled with this de novo approval, which establishes the new FDA category of cardiovascular machine learning-based notification software. The ongoing investment of innovative capabilities on our platform is why it continues to be the first choice of leading healthcare systems.”
One of the key issues surrounding HCM care is the fact that the disease can be challenging to diagnose. According to Matthew Martinez, MD, a cardiologist familiar with Viz HCM, adding AI tools to the arsenals of cardiologists could make a significant difference going forward.
“Given the high prevalence of patients with suspected HCM who remain undiagnosed, flagging and connecting them quickly to the right providers is critical to improve health outcomes,” Martinez, director of sports cardiology and HCM with the New Jersey-based Atlantic Health System, said in the same statement. “The role of AI in cardiology is growing exponentially and adding the HCM module to Viz.ai will help increase awareness and reach for HCM patients.”
The Viz HCM module has already been fully integrated into the company’s all-in-one care coordination system, the Viz.ai Platform. The platform now includes 12 FDA-cleared AI models designed to identify key findings and alert physicians when necessary.
Bristol Myers Squibb collaboration already paying off for Viz.ai
Back in March, Viz.ai announced a multi-year agreement with Bristol Myers Squibb (BMS) focused on helping bring its Viz HCM algorithm across the finish line and into the hands of healthcare providers. BMS is also the pharmaceutical company behind mavacamten, the first medication approved by the FDA for the treatment of obstructive HCM. The 2022 approval of mavacamten, sold and marketed under the name Camzyos, was seen as a key moment for the healthcare industry, leading to a heightened interest in HCM treatment among researchers, imaging specialists and vendors alike.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.